What is the overall process involved if my company is interested in working with the CNDSR?
A step-by-step overview can be viewed by clicking here.
Which part of product development/testing does the CNDSR support?
The CNDSR supports companies at most stages of product development/testing, from assay development, to proof-of-concept animal studies, to full scale human clinical trials. Please click here to see our list of services.
What kind of information would need to be disclosed during the initial phase of discussion in order to receive a quote? How long will it take to receive a quote for a study to be performed?
First, note that a non-disclosure agreement is often signed prior to any discussions taking place. For the most accurate quote, the CNDSR would need to understand basic information including the nature of the product to be tested (i.e., proposed use), outcomes measures to be included, sample size, and timeline. Our team will then consider this information in developing a study scope of work. This will be discussed with the company. Once the scope of work is agreed upon, the budget can typically be provided to the company in less than one week.
How is intellectual property handled?
Details related to intellectual property are defined within the contract. The company retains rights to all intellectual property that was owned by the company prior to project initiation.
What is the typical cost of conducting a study within the CNDSR?
Studies conducted in the CNDSR are more affordable than you may think. The cost varies depending on the nature of the design. Some small scale pilot (proof of concept) projects may cost less than $20,000, while more complex human clinical trials may be considerably more. The main variable influencing project cost is sample size (number of subjects or animals) and outcome measures included. We encourage companies to contact us to learn how affordable a high quality project can be.
What is the lead time for getting a study approved from the regulatory bodies such as the IRB or IACUC?
Approval from the IRB or IACUC typically takes between three and eight weeks from the time of initial protocol submission.
What is your study start-up time?
Depending on the type and complexity of the protocol, the study can usually begin within three to eight weeks of contract execution. This timeline assumes on-time approval of IRB or IACUC protocols. Experiments that do not involve human subjects or animals may be started even sooner.
What documents do you provide at the end of a study?
A complete study report is provided to the sponsor, often in the format of a scientific manuscript. This report is comprised of the study synopsis, detailed study design and plan, treatment description, efficacy and safety variables as appropriate, outcome variables, analysis, complete study results with tables and figures, discussion, overall conclusions, and references.
Do you support selling products?
As an independent third party research group, we do not endorse or sell any nutraceutical or dietary supplements direct to consumers.